News

The Burlington, North Carolina lab services and diagnostics company has licensed rights to an Alzheimer’s diagnostic technology from OPKO Health (NYSE:OPK). The deal gives LabCorp exclusive rights to the OPKO technology in North America and the United Arab Emirates. No financial terms were disclosed.

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The U.S. Food and Drug Administration issued new guidelines Tuesday to help device makers understand how FDA reviewers evaluate premarket approval for high-risk devices and de novo submissions for moderate risk devices.

In doing so, the agency reiterated a desire to provide clarity, consistency and transparency to a process that device manufactures have often charged as unpredictable, capricious and confusing.

“In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Jeff Shuren, director for the Center for Devices and Radiological Health, in a news release.

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Data from two trials at the American College of Cardiology (ACC; Washington) 61st Annual Scientific Session and Expo, 2012 suggests that Medtronic's (Minneapolis) renal denervation system provides a significant benefit to patients suffering from treatment-resistant hypertension.

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Gilero Biomedical a leading provider of medical device and pharmaceutical delivery device design and development services, announced that the company has received ISO 13485 certification for its quality management system. ISO 13485 is an internationally recognized quality standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet customer and regulatory requirements for design and development of medical devices.

"The ISO certification is a significant accomplishment and an important milestone for Gilero’s 10th year in business. Certification has been one of our top business priorities because it is important to our customers. It affirms that our Quality Management System meets the highest standards and strengthens Gilero's commitment to product quality and customer service," said Ted Mosler President & CTO.

It's the 2nd buyout this week for Covidien, which confirmed on Monday that it would acquire pulmonary device maker superDimension for $300 million plus possible earnouts in a deal expected to close during the 2nd quarter.

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The US Food and Drug Administration will launch a pilot program in June allowing medical device manufacturers to submit ISO 13485:2003 quality system audits in order to satisfy FDA 21 CFR Part 820 inspection requirements for one year.

Currently, the US regulator requires all domestic and foreign manufacturers to comply with 21 CFR Part 820 (also known as FDA Good Manufacturing Practice, or FDA GMP) quality system rules. By allowing firms the opportunity to avoid FDA inspection requirements for one year via ISO 13485 audit submissions, the agency seems to be aligning itself in this regard more closely to Global Harmonization Task Force (GHTF) guidelines.

 Aerocrine to Add 45 Jobs in Wake County

State Grant Helps Company Locate North American Headquarters in Morrisville

RALEIGH – Gov. Bev Perdue announced today that Aerocrine Inc., a medical technology company, will locate its North American headquarters in Wake County. The company plans to create 45 jobs and invest $219,000 during the next three years in Morrisville. The project was made possible in part by a $50,000 grant from the One North Carolina Fund.

“We have built a business climate where future-oriented industries, such as medical technology, can thrive in a global market,” Gov. Perdue said. “And our past investments in education and job training have yielded a top-notch workforce that companies like Aerocrine can count on.”

Industry stakeholders and FDA representatives came to terms on a tentative agreement early last month to double the user fees medical device companies pay for agency review, from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals.

With OMB approval in hand, the FDA announced a public workshop set for March 28 to allow stakeholders to present their views on the MDUFMA III recommendations as negotiations come to a close.

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ZOLL shares jumped 23.5% to $92.74 in morning trading today, after the Chelmsford, Mass.-based resuscitation device maker said it reached an agreement to merge with Asahi.

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Although the industry is still saddled with the unfavorable macro environment, it is expected to fare relatively better in 2012 thanks to several attractive growth opportunities and healthy tailwinds including improving hospital spending, emerging markets and pent-up demand.

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